February, 2003
© 2000, 2001 Scott S. Emerson, M.D., Ph.D.
Session 3: 68
Monitoring Secondary Endpoints
Statistical issues when using aggregate statistics to examine the safety profile
When examining the safety profile statistically, must consider multiple comparison problems
·over multiple adverse experience categories
-(the DSMB is largely on their own)
·over multiple analyses of the accruing data
-(group sequential methods can be used as a guideline)